MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT ESTRADIOL REAGENT KIT; RADIOIMMUNOASSAY, ESTRADIOL

Model Number	7K72-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a false decreased architect estradiol result for a patient.The following data was provided: on (b)(6) 2021 sid 210040034 = initial result = 235 pg/ml.On (b)(6) 2021 sid 210040034 = repeat result = >1000 pg/ml; repeat result (1:10 manual dilution) = 2085 pg/ml there was no impact to patient management reported.
Additional Manufacturer Narrative
The customer observed a falsely depressed patient result for 1 patient when using architect estradiol reagent lot 16081ui00.One qc outlier was subsequently found, and the kit was replaced with a new kit which provided acceptable results.A ticket search determined normal complaint activity for lot 16081ui00.The trending review identified no trends for lot 16081ui00 related to the issue.Return testing was not performed as returns were not available.Historical performance in the field of the reagent lot 16081ui00 using worldwide data was evaluated.The patient median result for lot 16081ui00 was analyzed and found to be comparable to all other lots in the field and confirms no systematic issue for the lot.The device history record was reviewed and identified no non-conformances or deviations for the reagent lot 16081ui00.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency for the architect estradiol assay, reagent lot 16081ui00 was identified.

• Brand Name: ARCHITECT ESTRADIOL REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 11187909
• Report Number: 3005094123-2021-00011
• Device Sequence Number: 3556930
• Product Code: CHP
• UDI-Device Identifier: 00380740014711
• UDI-Public: 00380740014711
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2021
• Device Model Number: 7K72-25
• Device Catalogue Number: 07K72-25
• Device Lot Number: 16081UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR MOD, 01L86-01, I1SR60760.; ARC I1000SR MOD, 01L86-01, I1SR60760.